Gottlieb had a private meeting (no media allowed) with five women who run the Essure Problems Facebook group comprising over 36,000 people, a handful of lawyers and Device Events Founder and CEO, Madras Tomes.
Essure and the FDA
Tomes is a former employee of the FDA, where she worked on its adverse event reporting program. She created a system whereby she can search the entire FDA medical device adverse events data since 1996 and she discovered hundreds of fetal deaths linked to Essure that Bayer neglected to report to the agency. She told this reporter that "Some women had died but I was seeing fetal deaths - miscarriage, ectopic pregnancy and stillbirth - checked as injury, while some checked under death were fetal death." She went on, "The FDA held an advisory panel meeting last September that included a presentation showing 25 deaths, five of which were fetal deaths. But if they aren't counting injuries such as miscarriage as fetal death, they are missing a lot."
Still, Tomes' findings weren't enough evidence for the FDA to withdraw Essure. Every other country has enough evidence to ban Essure - the U.S. is the only place where Bayer is still selling its device. The group brought to this meeting six years of documentation showing complications from the device, including photographic evidence of broken coils implanted in uteruses, body rashes, stillbirths, dissolved fallopian tubes, and dental problems that they claim were caused by the device, according to Buzzfeed.com.